Catalog Number 3095040 |
Device Problem
Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that it was not possible to open the cement sterile packaging.There was no surgical delay.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. device history lot a manufacturing record evaluation (nc search) was performed for the finished device product code: 3095040, lot: 3684071, and no non-conformances / manufacturing irregularities related to the malfunction were identified.
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Search Alerts/Recalls
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